Introduction

Risk benefit assessment is vital during the whole life cycle of products. For each medicine there is a balance between risk and benefit, but the perspective of different stakeholders (regulator, marketing authorisation holder, academic, patient, or prescriber) may vary. This course provides solid practical foundations which enable delegates to explore the relationship between risk and benefit, plus review the integration of appropriate strategies within risk management plans. Attendance at this course can be used as part of the training required for Higher Medical Training (HMT) and Pharmaceutical Medicine Specialty Training (PMST).

Aims

• To develop knowledge and understanding of the principles of risk benefit assessment, plus methods available for quantitative risk benefit analysis and their practical application in decision making
• To critically analyse factors associated with drug safety signals, the appropriate application of signal detection methodology and its contribution to safety monitoring and risk management
• To critically appraise with current regulatory legislation and guidelines relevant to risk management plans and recognise and justify their importance in helping ensure patient safety
• To analyse and review relevant documents for communicating risk benefit (including patient information leaflets, data sheets and safety alerts)
• To analyse recent challenges faced by regulators and marketing authorisation holders, critically review lessons learnt and outline future strategies for optimising pharmacovigilance activities to prevent withdrawal from the market

Programme features

• Principles of risk benefit assessment and management
• Familiarity with CIOMS IV report
• Evaluating signals
• Reporting and summarising safety data at registration and for the PSUR
• Variations, urgent safety restrictions, licence suspension and withdrawal
• European procedures and PDUFA III
• SPCs and PILs
• Crisis management